Computer System Validation (CSV) Specialist

Cencora

3d•Onsite

About The Position

Responsible for the MES Support and validation services. Primary focused on Syncade recipe configuration and validation. For this opportunity the resource will be working collaboratively with cross-functional teams including Manufacturing, Quality, Automation, and IT to ensure systems are configured, tested, and maintained in compliance with GMP and Computer System Validation (CSV) requirements.

Requirements

Bachelor’s degree in Science or Engineering

Nice To Haves

5+ years of experience in CSV in regulated environments
3+ years of hands-on experience with MES platforms, preferably Emerson Syncade, including development and maintenance of BI solutions.
Computer systems integrations and validation experience in regulated operations (preferably GMP operations).
Strong experience authoring and executing validation documentation (test scripts, protocols, reports).
Excellent technical and quality documentation skills in English, including validation deliverables and test evidence.
Able to use a logical, systematic approach to problem solving.
Ability to manage multiple priorities and work independently with limited supervision.
Strong communication, teamwork and collaboration skills.

Responsibilities

Supporting Syncade recipe configuration and maintenance, version control, and lifecycle management (e.g., Recipe Authoring, Equipment Tracking, Material Management, Workflow, Inventory)
Configure and maintain MES modules and workflows, ensuring alignment with site and global standards.
Configure and support MES integrations with ERP and automation systems (e.g., SAP, DCS, middleware).
Provide configuration-level troubleshooting and support root cause analysis for MES-related issues.
Execute and support CSV deliverables associated with Syncade configuration changes, including but not limited to: Risk assessments, URS / FRS reviews, test plans and test scripts, and IQ / OQ / PQ execution and summary reports.
Prepare and ensure validation documentation complies with GMP, CSV, and ALCOA+ data integrity principles.
Support change control impact assessments, deviations, and CAPA activities related to MES.
Support data validation and reconciliation activities for MES-related reports.
Participate in project meetings, design reviews, and deployment activities.